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Principal Statistical Programmer

Syneos Health
Syneos Health
8-12 years
preferred by company
Remote, India, India
1 May 13, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development

 

Job Title: Principal Statistical Programmer

Location: India (Remote)
Job Type: Full-Time
Experience Required: 8–12+ Years (Freshers are not eligible)
Industry: Biostatistics / Statistical Programming / Clinical Research / CRO / Pharmaceuticals / Biotechnology / Life Sciences
Department: Biometrics / Statistical Programming / Clinical Data Sciences

About the Role
We are seeking a highly experienced and technically advanced Principal Statistical Programmer to lead complex statistical programming initiatives supporting global clinical development programs, regulatory submissions, biometrics operations, and programming excellence. This senior-level leadership opportunity is ideal for professionals with deep expertise in SAS programming, CDISC standards, SDTM, ADaM, DEFINE.XML, TLF generation, validation programming, and regulatory statistical programming.

The ideal candidate will serve as a programming lead, technical subject matter expert, and strategic contributor to statistical programming operations, ensuring high-quality clinical data deliverables, regulatory compliance, and programming innovation across global studies.

This opportunity is highly suited for experienced biometrics professionals seeking leadership growth in statistical programming and clinical data sciences.

Key Responsibilities

Advanced Statistical Programming & Clinical Deliverables

  • Lead development of complex statistical programming deliverables using SAS and other statistical programming tools.
  • Generate and validate:
    • Summary tables
    • Data listings
    • Figures / graphs
    • Derived datasets
    • Analysis-ready clinical outputs
  • Translate Statistical Analysis Plans (SAPs) and programming specifications into validated, regulator-ready deliverables.
  • Ensure programming outputs meet sponsor expectations, quality standards, and clinical project timelines.

CDISC Standards & Regulatory Submission Programming

  • Lead implementation and governance of CDISC standards, including:
    • SDTM (Study Data Tabulation Model)
    • ADaM (Analysis Data Model)
    • DEFINE.XML documentation
  • Conduct compliance reviews for CDISC deliverables and regulatory submission datasets.
  • Support global submission readiness for agencies such as FDA, EMA, PMDA, and other regulatory authorities.
  • Maintain alignment with evolving industry and regulatory standards.

Programming Leadership & Technical Oversight

  • Act as the lead statistical programmer for assigned studies and programs.
  • Direct programming activities of other programmers, monitor deliverable progress, and ensure timeline adherence.
  • Review technical outputs, programming logic, validation results, and dataset specifications.
  • Resolve complex technical programming challenges proactively.

Validation Programming & Quality Control

  • Perform validation programming and programming quality control to ensure deliverable accuracy, consistency, and regulatory readiness.
  • Investigate discrepancies, troubleshoot issues, and collaborate with project teams to resolve findings efficiently.
  • Maintain strong documentation for testing, verification, QC, and inspection readiness.

Cross-Functional Collaboration & Stakeholder Engagement

  • Collaborate with:
    • Biostatisticians
    • Clinical data management teams
    • Clinical operations teams
    • Medical writers
    • Sponsor stakeholders
    • Regulatory teams
  • Participate in sponsor meetings, kickoff discussions, bid defense sessions, and technical planning meetings as statistical programming lead.
  • Communicate programming progress, risks, and mitigation plans proactively.

Project Management & Operational Delivery

  • Manage concurrent programming deliverables across multiple global projects.
  • Negotiate timelines, prioritize workloads, and adapt to changing business needs efficiently.
  • Maintain accountability for on-time delivery, resource coordination, and issue escalation management.

Technical SME Leadership & Standards Governance

  • Serve as a Subject Matter Expert (SME) for statistical programming methodologies, CDISC implementation, and regulatory data standards.
  • Provide technical guidance to biometrics teams and other departments on industry standards and compliance expectations.
  • Participate in industry standards initiatives and contribute updates on evolving programming requirements.

Programming Tools, Automation & Innovation

  • Contribute to development of programming utilities, reusable macros, automation frameworks, and efficiency-enhancing technical solutions.
  • Drive standardization across programming workflows and biometrics operational practices.

Training, Mentoring & Capability Development

  • Mentor junior programmers and support capability building through technical coaching, reviews, feedback, and formal training initiatives.
  • Develop and deliver internal programming training content and process guidance.
  • Support team development and technical excellence culture.

Documentation, SOPs & Compliance

  • Follow and help shape organizational:
    • SOPs
    • Work Instructions (WIs)
    • Programming standards
    • Regulatory programming procedures
  • Maintain well-organized project documentation supporting inspection readiness and audit compliance.